TriangleLABELS · b808a4e0-23a8-40c8-834d-b31cd642febe
Afinitor
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Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.
- Label effective date
- 2026-06-01
- Captured
- 2026-09-09T23:37:58.719708+00:00
- Current indication reconciliation
- Not reconciled
Indications and usage: exact source text
- 1 INDICATIONS AND USAGE AFINITOR is a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1 ) Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. ( 1.3 ) Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) AFINITOR DISPERZ is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. ( 1.6 ) 1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer AFINITOR ® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. 1.2 Neuroendocrine Tumors (NET) AFINITOR is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease. AFINITOR is indicated for the treatment of adult patients with progressive, well-differentiated, non-functional NET of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Limitations of Use: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors [see Clinical Studies (14.2)] . 1.3 Renal Cell Carcinoma (RCC) AFINITOR is indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib. 1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma AFINITOR is indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery. 1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) AFINITOR and AFINITOR DISPERZ ® are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected. 1.6 Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures AFINITOR DISPERZ is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.
Full extracted label fields
- application numbers
- NDA022334
- NDA203985
- boxed warning exact
- brand names
- Afinitor
- Afinitor Disperz
- current indication status
- not_reconciled
- dailymed set url
- https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=2150f73a-179b-4afc-b8ce-67c85cc72f04
- generic names
- EVEROLIMUS
- id
- b808a4e0-23a8-40c8-834d-b31cd642febe
- indications and usage exact
- 1 INDICATIONS AND USAGE AFINITOR is a kinase inhibitor indicated for the treatment of: Postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole. ( 1.1 ) Adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic. Limitations of Use: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors. ( 1.2 ) Adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. ( 1.3 ) Adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. ( 1.4 ) AFINITOR and AFINITOR DISPERZ are kinase inhibitors indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) AFINITOR DISPERZ is a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. ( 1.6 ) 1.1 Hormone Receptor-Positive, HER2-Negative Breast Cancer AFINITOR ® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane, after failure of treatment with letrozole or anastrozole. 1.2 Neuroendocrine Tumors (NET) AFINITOR is indicated for the treatment of adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) with unresectable, locally advanced or metastatic disease. AFINITOR is indicated for the treatment of adult patients with progressive, well-differentiated, non-functional NET of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease. Limitations of Use: AFINITOR is not indicated for the treatment of patients with functional carcinoid tumors [see Clinical Studies (14.2)] . 1.3 Renal Cell Carcinoma (RCC) AFINITOR is indicated for the treatment of adult patients with advanced RCC after failure of treatment with sunitinib or sorafenib. 1.4 Tuberous Sclerosis Complex (TSC)-Associated Renal Angiomyolipoma AFINITOR is indicated for the treatment of adult patients with renal angiomyolipoma and TSC, not requiring immediate surgery. 1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) AFINITOR and AFINITOR DISPERZ ® are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected. 1.6 Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures AFINITOR DISPERZ is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.
- indications and usage tables exact
- is original packager
- true
- manufacturer names
- Novartis Pharmaceuticals Corporation
- matched search terms
- cancer
- carcinoma
- tumors
- package ndcs
- 0078-0566-61
- 0078-0566-51
- 0078-0567-61
- 0078-0567-51
- 0078-0594-61
- 0078-0594-51
- 0078-0620-61
- 0078-0620-51
- 0078-0626-61
- 0078-0626-51
- 0078-0627-61
- 0078-0627-51
- product ndcs
- 0078-0566
- 0078-0567
- 0078-0594
- 0078-0620
- 0078-0626
- 0078-0627
- 0078-0628
- product types
- HUMAN PRESCRIPTION DRUG
- recent major changes exact
- Dosage and Administration ( 2.8 , 2.11 ) 6/2026
- record type
- complete_spl_indications_section_candidate
- routes
- ORAL
- rxcuis
- 845507
- 845512
- 845515
- 845518
- 998189
- 998191
- 1119400
- 1119402
- 1308428
- 1308430
- 1308432
- 1310138
- source batch
- file
- /private/tmp/cancer-full-research/indications/raw/labels-00600.json
- meta
- disclaimer
- Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
- last updated
- 2026-09-09
- results
- limit
- 100
- skip
- 600
- total
- 830
- sha256
- a9df7a5786dc51557d38f2a0881b5b5e9ae02ae396a6798e39ac96f586bcc5e6
- source url
- https://api.fda.gov/drug/label.json?search=id%3A%22b808a4e0-23a8-40c8-834d-b31cd642febe%22
- spl effective date
- 2026-06-01
- spl effective time
- 20260601
- spl set id
- 2150f73a-179b-4afc-b8ce-67c85cc72f04
- spl version
- 67
- substance names
- EVEROLIMUS
- uniis
- 9HW64Q8G6G
- verification flags
- oncology_keyword_candidate_not_clinically_classified
- spl_text_not_verified_identical_to_latest_approved_label
- individual_indications_not_split_or_reconciled
- fda_label_posted_after_spl_effective_date_requires_version_review
Drugs@FDA application source records
- application number
- NDA022334
- payload
- all indexed label documents
- Appl No
- 022334
- Application Docs Date
- 2009-04-03 00:00:00
- Application Docs ID
- 17254
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022334lbl.pdf
- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 022334
- Application Docs Date
- 2010-05-17 00:00:00
- Application Docs ID
- 17255
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s001lbl.pdf
- Submission No
- 1
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2010-07-12 00:00:00
- Application Docs ID
- 17256
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s004lbl.pdf
- Submission No
- 4
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2010-11-01 00:00:00
- Application Docs ID
- 17257
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022334s6lbl.pdf
- Submission No
- 6
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2011-05-06 00:00:00
- Application Docs ID
- 17258
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022344s9s10lbl.pdf
- Submission No
- 9
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2012-04-02 00:00:00
- Application Docs ID
- 17259
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s014s015.pdf
- Submission No
- 14
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2012-08-31 00:00:00
- Application Docs ID
- 17260
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022334s018lbl.pdf
- Submission No
- 18
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2014-02-21 00:00:00
- Application Docs ID
- 17261
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
- Submission No
- 21
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2013-11-08 00:00:00
- Application Docs ID
- 17262
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf
- Submission No
- 22
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2014-02-21 00:00:00
- Application Docs ID
- 17263
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
- Submission No
- 24
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2014-07-02 00:00:00
- Application Docs ID
- 17264
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf
- Submission No
- 25
- Submission Type
- SUPPL
- Appl No
- 022334
- Application Docs Date
- 2014-12-19 00:00:00
- Application Docs ID
- 17265
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s027lbl.pdf
- Submission No
- 27
- Submission Type
- SUPPL
- all submission records
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 55
- Submission Status
- AP
- Submission Status Date
- 2026-06-01 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 51
- Submission Status
- AP
- Submission Status Date
- 2022-02-01 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 50
- Submission Status
- AP
- Submission Status Date
- 2021-12-30 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 47
- Submission Status
- AP
- Submission Status Date
- 2021-04-16 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 45
- Submission Status
- AP
- Submission Status Date
- 2020-01-22 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 44
- Submission Status
- AP
- Submission Status Date
- 2020-02-13 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 40
- Submission Status
- AP
- Submission Status Date
- 2018-04-10 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 2
- Submission No
- 39
- Submission Status
- AP
- Submission Status Date
- 2017-09-26 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 38
- Submission Status
- AP
- Submission Status Date
- 2016-06-14 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 36
- Submission Status
- AP
- Submission Status Date
- 2016-02-26 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- PRIORITY
- Submission Class Code ID
- 2
- Submission No
- 35
- Submission Status
- AP
- Submission Status Date
- 2016-02-18 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 022334
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 34
- Submission Status
- AP
- Submission Status Date
- 2016-02-04 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- application number
- NDA022334
- approval interpretation
- Application linkage and approved submission are not indication-level current approval verification
- current indication status
- not_reconciled
- drugsfda url
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022334
- has approved submission record
- true
- latest approved submission date
- 2026-06-01
- latest label selection rule
- max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
- latest posted label documents
- Appl No
- 022334
- Application Docs Date
- 2026-06-02 00:00:00
- Application Docs ID
- 86120
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/022334s055lbl.pdf
- Submission No
- 55
- Submission Type
- SUPPL
- official application record
- Appl No
- 022334
- Appl Public Notes
- Appl Type
- NDA
- Sponsor Name
- NOVARTIS
- openfda application present
- true
- products
- Active Ingredient
- EVEROLIMUS
- Appl No
- 022334
- Drug Name
- AFINITOR
- Form
- TABLET;ORAL
- Product No
- 001
- Reference Drug
- 1
- Reference Standard
- 1
- Strength
- 5MG
- marketing status
- Prescription
- Active Ingredient
- EVEROLIMUS
- Appl No
- 022334
- Drug Name
- AFINITOR
- Form
- TABLET;ORAL
- Product No
- 002
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- 10MG
- marketing status
- Prescription
- Active Ingredient
- EVEROLIMUS
- Appl No
- 022334
- Drug Name
- AFINITOR
- Form
- TABLET;ORAL
- Product No
- 003
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- 2.5MG
- marketing status
- Prescription
- Active Ingredient
- EVEROLIMUS
- Appl No
- 022334
- Drug Name
- AFINITOR
- Form
- TABLET;ORAL
- Product No
- 004
- Reference Drug
- 1
- Reference Standard
- 0
- Strength
- 7.5MG
- marketing status
- Prescription
- application number
- NDA203985
- payload
- all indexed label documents
- Appl No
- 203985
- Application Docs Date
- 2012-08-29 00:00:00
- Application Docs ID
- 19506
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/203985s000lbl.pdf
- Submission No
- 1
- Submission Type
- ORIG
- Appl No
- 203985
- Application Docs Date
- 2014-02-21 00:00:00
- Application Docs ID
- 19507
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
- Submission No
- 5
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2014-07-02 00:00:00
- Application Docs ID
- 19508
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s025203985s007lbl.pdf
- Submission No
- 7
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2015-01-29 00:00:00
- Application Docs ID
- 19509
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/203985s008lbl.pdf
- Submission No
- 8
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2014-02-21 00:00:00
- Application Docs ID
- 40334
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
- Submission No
- 2
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2013-11-08 00:00:00
- Application Docs ID
- 40335
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022334s022lbl.pdf
- Submission No
- 3
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2014-02-21 00:00:00
- Application Docs ID
- 40336
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022334s021s023s024,203985s002s004s005lbl.pdf
- Submission No
- 4
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2016-02-02 00:00:00
- Application Docs ID
- 40337
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022334s032,203985s010lbl.pdf
- Submission No
- 10
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2018-04-11 00:00:00
- Application Docs ID
- 53648
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022334s040,203985s013lbl.pdf
- Submission No
- 13
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2020-01-23 00:00:00
- Application Docs ID
- 61630
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s045,203985s017lbl.pdf
- Submission No
- 17
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2020-02-14 00:00:00
- Application Docs ID
- 61892
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022334s044,203985s016lbl.pdf
- Submission No
- 16
- Submission Type
- SUPPL
- Appl No
- 203985
- Application Docs Date
- 2021-04-19 00:00:00
- Application Docs ID
- 67104
- Application Docs Title
- 0
- Application Docs Type ID
- 2
- Application Docs URL
- http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022334s047,203985s020lbl.pdf
- Submission No
- 20
- Submission Type
- SUPPL
- all submission records
- Appl No
- 203985
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 28
- Submission Status
- AP
- Submission Status Date
- 2026-06-01 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 203985
- Review Priority
- N/A
- Submission Class Code ID
- 4
- Submission No
- 27
- Submission Status
- AP
- Submission Status Date
- 2024-03-11 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 203985
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 23
- Submission Status
- AP
- Submission Status Date
- 2022-02-01 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 203985
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 20
- Submission Status
- AP
- Submission Status Date
- 2021-04-16 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
- 203985
- Review Priority
- STANDARD
- Submission Class Code ID
- 3
- Submission No
- 17
- Submission Status
- AP
- Submission Status Date
- 2020-01-22 00:00:00
- Submission Type
- SUPPL
- Submissions Public Notes
- Appl No
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Preserved source evidence · Not medical advice